- PTAB · Nov 16, 2023 · IPR2023-01035 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–6, 8–10, and 22–28, finding a reasonable likelihood that Petitioner would prevail on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of the challenged claims of the ’048 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSITA”) would have had “a bachelor’s degree and two or more years of experience or a master’s degree in organic synthesis or chemical engineering, with education substituting for experience and vice versa.” Pet. 15 (citing Ex. 1002 ¶ 16). Patent Owner takes no position on” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“At this stage of the proceeding, we determine Petitioner’s construction is most consistent with the plain ordinary meaning of “about” and the intrinsic evidence. The claim recites that the carbon chain length of the resulting bio-alkene is “about 5 to about 20.” Ex. 1001, claim 1 (emphasis added). We agree with Petitioner that use of the term “about” indicates a lack of specificity with respect to the claimed range. See Cohesive Techs., Inc. v. Waters. Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (“When ‘about’ numeric boundary to the specified parameter.”) (internal quotations omitted). In other words, the claim term “about 5 to about 20” does not require precisely 5 to 20 carbons. Moreover, we agree that a carbon atom in a compound is not divisible. Keeping these principles in mind, we find “about 5” at the lower end of the range encompasses at least a carbon chain length of 4, and “about 20” at the upper end of the range encompasses at least a carbon chain length of 21. We also agree with Petitioner that the prosecution history of the parent application supports construing “about” to encompass one additional carbon atom, as evidenced by the amendment after allowance amending the term “carbon chain length of about 8” to “carbon chain length of 7.” See Ex. 1006, 335. Thus, the intrinsic evidence supports Petitioner’s construction and the plain ordinary meaning of “about.”” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“institution under 35 U.S.C. § 325(d) for only these grounds (i.e., Grounds 5 and 6). Prelim. Resp. 19–25. Specifically, Patent Owner argues that Wright was considered by the Office and Petitioner has failed to demonstrate that the Office erred in any material way. Id. Even if we found Patent Owner’s arguments persuasive, after the Supreme Court’s decision in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018), we are compelled to proceed with this inter partes review on all grounds raised in the Petition because we find above. See Guidance on the impact of SAS on AIA trial proceedings, available at https://www.uspto.gov/patents/ptab/trials/guidance-impact-sasaia-trial (“If the PTAB institutes a trial, the PTAB will institute on all challenges raised in the petition.”). Thus, we find Patent Owner’s § 325(d) arguments to be moot.” slip op. at 20
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,995,048 - PTAB · Oct 20, 2023 · IPR2023-00739 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claims 10–12, 18, 19, 21, and 26–28 are obvious over the 2009 Press Release and Shams.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Release nor Shams expressly teaches the dosing regimen of “2 mg approximately every 4 weeks for the first 5 injections followed by 2 mg approximately once every 8 weeks or once every 2 months,” as recited in the independent claims. However, the question guiding our analysis is not one of anticipation, but of obviousness. Specifically, the question is whether the differences between the claimed subject matter and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. KSR, 550 U.S. at 406. We therefore turn to that analysis.” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“We conclude that, on the record as presently developed, Petitioner has demonstrated a reasonable likelihood of success in demonstrating that a person of ordinary skill in the art would have found it obvious to modify the dosage regiment of the 2009 Press Release by adding a single dose at week twelve, in view of the teachings of Shams, to arrive at the claimed invention. We find that a person of ordinary skill in the art would have considered this addition of a single dose to be routine optimization to ensure, as Dr. Chaum relates, “to determine the optimal number of initial injections, before moving to eight-week dosing.” Ex. 1002 ¶ 151. Furthermore, and at this stage of the proceeding, we agree with Petitioner that a person of ordinary skill in the art would have had a reasonable expectation of success in modifying the 2009 Press Release dosing protocol to include an additional dose at week twelve to ensure sufficient “drying” of the inner wall of the retina prior to increasing the interval of the doses two eight weeks/two months.” slip op. at 36
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“claimed method. A reference teaches away when “a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Patent Owner points to Shams’ Example 1, which it cites as representing Genentech’s PIER Phase IIIb study. See Prelim. Resp. 18. The PIER study, argues Patent Owner involved three monthly loading doses of a different VEGF antagonist (ranibizumab) followed by quarterly dosing, and, according to Patent Owner, was widely perceived as a failure. Id. Patent Owner contends that, based upon this single example, a person of ordinary skill in the art would have been discouraged from following the teachings of Shams. Id. We disagree. As we have explained above, the disclosures of Shams encompass a larger variety of regimen options than merely that embodied in Example 1. Shams is directed expressly to “methods including administering … a number of first individual doses of a VEGF antagonist, followed by administering … a number of second individual doses of the antagonist, wherein the second individual doses are administered less frequently than the first individual doses.” Ex. 1010, 4–5; see also id., claim 1. Furthermore, Shams expressly teaches that “[t]he doses may be administered according to any time schedule which is appropriate for treatment of the disease or condition.” Id. at 22. We find that these broad teachings of Shams would, rather than discouraging a skilled artisan from following its teachings, encourage a person of ordinary skill in the art to optimize the number of first and second individual doses to maximize the therapeutic effect of the regimen of VEGF antagonist dosage administration. Shams places no express limits upon the number of first individual doses and, as we have explained above, the addition of a single additional dose at week twelve would fall well within the scope of Shams’ disclosures.” slip op. at 38
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“A method for treating….” Petitioner initially accepts, for the purposes of this Decision, that the preamble of claim 1 is limiting, and agrees with the Board’s prior rejection, in the related IPR2021-00881 Final Written Decision, of Patent Owner’s position that the preamble requires a particular level of efficacy. Pet. 16 (citing Ex. 1002 ¶¶ 82–91). Specifically, Petitioner notes that the Board found that administering a compound—the recited VEGF antagonist—“to [a] patient for the purpose of improving or providing a beneficial effect on their angiogenic eye disorder” satisfies the “treating” portion of the preamble. Id. at 17 (quoting Ex. 1025, 19; and citing id. at 23; Ex. 1053, 9– 10; Ex. 1054). Patent Owner states that, for the purposes of this Decision only, it does not contest Petitioner’s proposed construction. Prelim. Resp. 11. Therefore, for the same reasons we explained in the Final Written Decision in related IPR2022-00881 concerning a related patent having claims with language similar to the presently challenged claims, and for the purposes of this Decision, we adopt Petitioner’s proposed construction of “a method for treating….” slip op. at 8
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,888,601 - PTAB · Oct 12, 2023 · IPR2023-00614 · APJ Zhenyu Yang · IPR · Institution
The Board instituted review of claims 1–3, 6–18, 21–24, and 27–29 on all asserted grounds, finding a reasonable likelihood of obviousness over Ducharme, Ianiro, Katzir, and Hasnain.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Patent Owner has not persuaded us to exercise our discretion to deny institution. Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, 8. We focus our analysis on Ducharme, one of the primary references asserted in the Petition. Although Ducharme was “not before the Office during examination of the [’]895 Patent,” Patent Owner asserts that it is cumulative to a reference that “was presented to the Office during examination by IDS.” Prelim. Resp. 42–43. Patent Owner does not point to, and we have not found, any evidence showing discussion or application of the previously presented reference by the Examiner during prosecution of the ’895 patent or its related patents. In other words, “the record of the Office’s previous consideration of the art is not well developed or silent.” Advanced Bionics, 10. In such situations, “a petitioner may show the Office erred by overlooking something persuasive.” Id.; see also id. at 8 n.9 (“An example of a material error may include misapprehending or overlooking specific teachings of the relevant prior art where those teachings impact patentability of the challenged claims.”). On this record, Petitioner has shown sufficiently that the Examiner overlooked Ducharme’s teachings of the limitations that were the basis for allowing the challenged claims. Indeed, the Examiner allowed the challenged claims, stating that the closest prior art references lack the teachings of the emitted light being suitable for the commercial image recording when the emitted light is simultaneously at least 1000 lumens when either the first or the second LEDs are lit, is broad-spectrum white light having a color deviation corresponding to less than 5 points of both green and magenta of color compensation, and has a color rendering index of light emitted from each of the first or the second LEDs (whichever is lit) that is greater than 90. Ex. 1002, 150. Petitioner’s evidence indicates that Ducharme teaches an LED light suitable for commercial image recording that includes a plurality of first white LEDs having a first spectrum and a plurality of second white LEDs having a second spectrum. See, e.g., Ex. 1005, 4:1–7. Petitioner’s evidence also indicates that a person of ordinary skill in the art would have had reason to select first white LEDs with a daylight spectrum and second white LEDs with a tungsten spectrum. See, e.g., Ex. 1003 ¶ 449; Ex. 1006 ¶ 53. Further, Petitioner’s evidence indicates that LEDs satisfying the light quality parameters recited in the challenged claims were known to those of ordinary skill in the art. See, e.g., Ex. 1003 ¶ 480; Ex. 1005, 25:36–43; Ex. 1007, 7:11–15; Ex. 1008, 4:1–3. Thus, the evidence cited in the Petition demonstrates that the Office” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 14; Prelim. Resp. 14. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LEDs.” Pet. 14 (citing Ex. 1003 ¶ 32). Patent Owner does not dispute Petitioner’s definition of the skill level at this stage of the proceeding. Prelim. Resp. 13. For purposes of this Decision, we adopt Petitioner’s definition of the skill level because it is consistent with the prior art’s demonstration of the skill level at the time of the invention.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 10,566,895 - PTAB · Oct 10, 2023 · IPR2023-00611 · APJ Christopher L Crumbley · IPR · Institution
The Board instituted IPR on claims 1, 3, 4, 7–13, 23, 25, 26, 28, 29–39, and 41–45 on all asserted grounds, finding a reasonable likelihood of success over Mueller, Ansems, and Simon.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a) (2022). The standard for instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted unless “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“whether the Office erred in a manner material to the patentability of the challenged claims. Advanced Bionics, Paper 6 at 8. Central to this analysis is factor (c) of Becton, Dickinson, which “focuses on the record developed by the Office in previously reviewing the art or arguments.” Id. at 10. In cases where the Office raised a specific teaching of a reference during prosecution, and the petitioner disagrees with that specific finding of record, “then ordinarily the petitioner’s required showing of material error must overcome persuasively that specific finding of record.” Id. On the other hand, we are often presented with circumstances such as those found in the present case, where the prior art that was previously presented to the Office was not substantively remarked upon or applied in a rejection of the claims. This often occurs in the context of art submitted on an IDS, which is the manner in which the majority of the references identified by Colt in this case were incorporated into the file history. Ex. 1002, 216 (Kit, Ducharme ’261, Mueller ’029), 217 (Katzir). Only Simon” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Skill Quasar asserts that a person of ordinary skill in the art at the time of the invention would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LED lights.” Pet. 16 (citing Ex. 1003 ¶¶ 32–33). Colt does not dispute Quasar’s characterization of the level of skill, arguing that “the proposed level of ordinary skill does not affect the ultimate analysis.” Prelim. Resp. 15. At this stage of the proceeding, we adopt Quasar’s definition of the level of skill in the art, which is consistent with the disclosure of the ’224 patent and asserted prior art of record. If the parties disagree with our preliminary finding, they are invited to further brief the issue of level of ordinary skill in the art and, in particular, which disputed issues material to patentability turn on the definition adopted by the Board.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“35 U.S.C. § 282(b), as articulated in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc), and its progeny. See 37 C.F.R. § 42.100(b) (2022). Under this standard, the words of a claim are generally given their “ordinary and customary meaning,” which is the meaning the term would have to a person of ordinary skill at the time of the invention, in the context of the entire patent including the specification. See Phillips, 415 F.3d at 1312–13. Both parties agree that the terms of the claims of the ’224 patent should be given their ordinary and customary meaning, but neither party further elaborates on what those meanings are for any particular claim term. Pet. 16–17; Prelim. Resp. 15. We interpret the parties’ positions to be that no claim term of the ’224 patent requires express construction for purposes of deciding whether to institute trial. Upon review of the record and the parties’ arguments, we agree. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 10,197,224 - PTAB · Oct 10, 2023 · IPR2023-00613 · APJ Robert J Weinschenk · IPR · Institution
Instituted IPR on claims 1–3, 6–14, 16–19, 21–24, and 26–31 on all petitioned grounds; petitioner showed a reasonable likelihood of prevailing on obviousness over Ducharme, Ianiro, Katzir, and Hasnain.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 6
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“would have been obvious over Ducharme, Ianiro, Katzir, and Hasnain. Pet. 47–75. For the reasons discussed below, Petitioner demonstrates a reasonable likelihood of prevailing in showing that claims 1–3, 6–14, 16–19, 21–24, and 26–31 would have been obvious over Ducharme, Ianiro, Katzir, and Hasnain.” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner argues that a person of ordinary skill in the art would have had “at least a Bachelor of Science degree in electrical engineering, or a closely related field, along with at least two years of experience in the design of entertaining lighting systems, and the design and use of LED lights.” Pet. 13 (citing Ex. 1003 ¶ 32). Petitioner’s description of the level of ordinary skill in the art is supported by the testimony of Petitioner’s declarant, Mr. Fred Holmes. Ex. 1003 ¶ 32. Patent Owner does not dispute Petitioner’s description at this stage of the proceeding. Prelim. Resp. 12. We adopt Petitioner’s description for purposes of this Decision.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction In an inter partes review proceeding, a patent claim is construed using the same standard used in a civil action under 35 U.S.C. § 282(b), including construing the claim in accordance with the ordinary and customary meaning of the claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. 37 C.F.R. § 42.100(b). Neither party proposes an express construction for any claim terms at this stage of the proceeding. Pet. 13; Prelim. Resp. 12–14. We determine that no claim terms require express construction for purposes of this Decision.” slip op. at 9
Claim construction§ 103 obviousnessDiscretionary denialPatents in suitUS 10,411,582 - PTAB · Oct 4, 2023 · IPR2023-00724 · APJ Susan L C Mitchell · IPR · Institution
The Board instituted IPR on claims 1–10, finding a reasonable likelihood that claim 1 is anticipated by WO421 and Lovshin and obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“The Examiner’s statement that NCT657 “does not teach or disclose a higher amount of 1 mg semaglutide” is incorrect and also fails to consider the teachings of the dosing ranges of WO421 and Lovshin, and the maximum dose of 1.2 mg of semaglutide taught in NCT773. For these reasons, we determine that Petitioner has sufficiently demonstrated a material error on the part of the Examiner, and we therefore decline to exercise our discretion to deny institution of inter partes review under 35 U.S.C. § 325(d).” slip op. at 15
- Other 314aInstitution denied discretionary otherDecided for petitioner
“Petition under Section 314(a), “particularly in light of the significant §325(d) concerns regarding Grounds 1 and 2—which address only claims 1–3—and in view of the substantive infirmities of Ground 3–5.” Prelim. Resp. 66–67. Patent Owner does not address Petitioner’s assertions that a trial here would most likely conclude before the parallel Delaware litigation, and Petitioner’s stipulation “that if the Board institutes, Petitioner will not pursue in the district court any instituted grounds against the originally-issued claims unless a change in law otherwise permits.” Pet. 65–66 (citing Sand Revolution II, LLC v. Cont’l Intermodal Grp., IPR2019-01393, Paper 24, 12 (PTAB June 16, 2020)). We do not agree with Patent Owner’s assertions concerning Section 325(d) as set forth above, and find nothing here that would warrant the exercise of our discretion to deny institution based on 35 U.S.C. § 314(a) to deny institution of an otherwise meritorious petition.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“VI. CONCLUSION Based on the current record, we determine Petitioner has shown a reasonable likelihood that it will prevail in establishing that at least one claim of the ’462 patent is unpatentable. Accordingly, we institute review of all claims challenged on all of the grounds in the Petition. See Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019), 64, available at https://www.uspto.gov/ sites/default/files/documents/tpgnov.pdf. At this stage of the proceeding, the Board has not made a final determination as to the patentability of any challenged claim. Our view with regard to any conclusion reached in the foregoing analysis could change upon completion of the record. VII. ORDER Accordingly, it is: ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review is hereby instituted as to claims 1–10 of the ’462 patent based on the unpatentability challenges presented in the Petition; and” slip op. at 39
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“Here, we agree with the parties that the preamble of claim 1 is limiting. The preamble provides context for the requirement of claim 1 that administration of the semaglutide is “to a subject in need thereof.” See Ex. 1001, 35:42–44. The preamble, when read in the context of the entirety of claim 1, recites a limitation of administering semaglutide to a subject with type 2 diabetes. Based on the constructions of the preamble provided by the parties, it appears they agree that the preamble does not require any particular level of efficacy. We agree. The Specification of the ’462 patent makes clear that “treatment” or “treating” as used in the ’462 patent does not require any particular degree of efficacy as these terms include the “full spectrum” of treatments for a condition. See Ex. 1001, 5. For instance, the Specification of the ’462 patent provides: In one embodiment the term “treatment” or “treating” as used herein means the management and care of a patient for the purpose of combating a condition, such as a disease or a disorder. In one embodiment the term “treatment” or “treating” is intended to include the full spectrum of treatments for a given condition from which the patient is suffering, such as administration of the active compound to alleviate the symptoms or complications; to delay the progression of the disease, disorder or condition; to alleviate or relieve the symptoms and complications; and/or, to cure or eliminate the disease, disorder, or condition as well as to prevent the condition. Ex. 1001, 5:16–27.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 10,335,462 - Cisco Systems, Inc. v. Ramot At Tel Aviv University, Ltd.No claims unpatentablePTAB · Oct 3, 2023 · IPR2022-00576 · APJ Monica S Ullagaddi · IPR · Final written decision
Claims 13, 14, and 23–29 were not shown unpatentable as obvious over Roberts and Taraschuk, with or without Wright, because the asserted combinations did not teach or suggest the claimed delta features.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“We do not discern a substantial difference between the parties’ definitions for the level of ordinary skill in the art. Instead, we determine that the parties’ definitions are substantially similar. We adopt Petitioner’s definition of the level of skill in the art, which is consistent with the disclosure of the ’872 patent and asserted prior art of record. The findings and conclusions rendered in this Decision would not change had we adopted Patent Owner’s definition.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not construe any claim term in our Decision in order to resolve the issues before us. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that construction is needed only for terms that are in dispute, and only as necessary to resolve the controversy).” slip op. at 9
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable
“for a LUT having the recited deltas except for Dr. Blumenthal’s analysis. Although Wright generally teaches compensating for mismatches, Dr. Blumenthal’s analysis fills in limitations 13.8 and 13.9––Petitioner does not set forth a sufficiently supported reason for using the specific values recited in limitations 13.8 and 13.9. At best, Petitioner presents an “obvious to try rationale”: In addition to the reasons mentioned above, a POSITA would have found it obvious to try a mapping scheme in which entries in the look-up table as taught by Taraschuk are selected such that successively decreasing inputs correspond to digital output entries with either decreasing, increasing, or similar deltas between their values. . . . Doing so would have involved choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. In that regard, the deltas between values of the corresponding digital outputs can either increase, decrease, or stay the same. Accordingly, there are only three possible relationships between deltas of successive digital outputs. With so few possibilities, a POSITA would have found it obvious to try each of them. Pet. 59 (citing Ex. 1003 ¶ 265). The analysis for 13.8 is incorporated by reference in 13.9. See Pet. 60. Although there are three possible relationships between two, consecutive deltas, there are many possible sequences of deltas––Petitioner does not sufficiently show a finite number of solutions in its challenge.” slip op. at 30
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner’s argument that the portions of Taraschuk in column 7, lines 61–67 and column 8, lines 13–15 cited by Petitioner in its challenge to claim 13 teach “an end-to-end approach” “because that calculation involves predistortion of the input M-bit word by subtracting a digitized analog sample of the ultimate output,” and as such, teach “[a]n approach that necessarily does one combined correction for all of the nonlinearities that occur in-between those ends—whether bit mismatches in the digital logic or non-linearities in the Mach-Zehnder modulator.” PO Sur-reply 18 (citing PO Resp. 30–36; Ex. 2018 ¶¶ 48, 49, 85–87, 89, 103; Ex. 1006, 7:34–39, 7:61–67). We further agree with Patent Owner’s assertion that [Patent Owner] and Prof. Dallesasse are not suggesting that Dr. Blumenthal should model the logic-level mismatches. But rather pointing out that calculating an idealized sinusoidal response in isolation is not obvious (or flowing naturally) from a reference that can only deal with compensating the combined response of the modulator and digital logic mismatches together—via real-time pre-distortion fed back from the ultimate output and subtracted from the input. Dallesasse testifies that Dr. Blumenthal starts with the premise that all that is required is deriving a complementary function to the sinusoidal response. . . . But this ignores that the disclosure of Taraschuk describes compensating “the sinusoidal response of the modulator” and “logic level mismatches through the D/A converter” together. . . . Dr. Blumenthal’s complementary sinusoidal correction curve won’t do that. The combined non-linearity from the multiple sources likely won’t simply be evenly sinusoidal. Taraschuk does not disclose, or in my opinion render obvious, any pre-calculation solution. (Taraschuk mentions a real-time analog feedback loop to pre-distort, which would not involve pre-calculation.) And it certainly does not suggest one that could deal with the combined and likely complex non-linearities described.” slip op. at 28
Patent outcomesUS 11,133,872 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,133,872 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 Patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122 - Cisco Systems, Inc. v. Ramot At Tel Aviv University, Ltd.No claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00575 · APJ Monica S Ullagaddi · IPR · Final written decision
Claims 1–12, 15–22, and 30 were not shown unpatentable under § 103 over Roberts and Taraschuk because the combination did not teach or suggest the claimed mapping.
RulingsFinal written decision- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“Inst. Dec. 25–26 (citing Ex. 1006, 8:2, 8:8, 6:61–65; Ex. 1003 ¶ 147; Prelim. Resp. 46). Based on our review of the complete record developed during trial, we are persuaded to modify our preliminary determinations. For the reasons discussed below, we are persuaded that the scope of claim 1 does not encompass linear compensation methods effected by analog pre-distortion because the ’872 patent specification distinguishes analog pre-distortion (see Ex. 1001, 1:55–2:34) and the prosecution history specifically distinguishes analog pre-distortion from the claimed approach (see Ex. 1002, 172). We find persuasive Dr. Dallesasse’s testimony that “a person of ordinary skill in the art reading the [’872] patent would understand that th[e] [claimed] approach differs from pre-distortion based on real-time measured analog modulator output.” Ex. 2018 ¶ 33 (citing-in-part Ex. 1001, 2:3–7 (’872 patent disclosing common, prior art solutions such as “an analog predistortion circuit to feed the modulator”)); see also Ex. 1001, (the ’872 patent describing the need for a “digital to analog converter” that would “improve[] linearity of response without sacrificing efficiency or dynamic range” as in the common, prior art solutions). Dr. Dallesasse explains how “the prosecution history of the ’872 patent [illustrates] that when [Patent Owner] changed ‘correct for non-linearities’ to the more specific language ‘determined based on a pattern for actuating drive voltages that alters the linearity of an optical response of the modulator,’” “the Examiner then allowed the claims over a rejection based on Roberts, which “suggests that there are ways to ‘correct for non-linearities’ that do not meet the amended Ex. 2009, 2; Ex. 2003). During prosecution, Patent Owner argued: Roberts does not disclose a “digital-to-digital mapping,” where, “for a given plurality of N digital input data bits, the mapping to the corresponding M digital output data bits is determined based on a pattern for actuating drive voltages that alters the linearity of an optical response of the modulator,” as recited in amended claim 1. Instead, the linear compensation in Roberts is performed pursuant to a compensation function c(t) when the Vx(n) multi-bit sample streams are generated. Importantly, this linear compensation in Roberts occurs before the mapping of Vx(n) to Sx(n). As a result, the mapping between Vx(n) to Sx(n) in Roberts, such as the mapping shown in Table 1 of Roberts, is not a part of the linear compensation operation performed in Roberts. Ex. 1002, 172 (emphasis added). We interpret the quoted passage to exclude analog pre-distortion because we interpret the argument distinguishing Robert’s compensation as happening “before the mapping” to refer to pre-distortion techniques––in particular, those accomplished by analog compensation function, c(t). Id. Both the ’872 patent and Patent Owner’s arguments during prosecution support Dr. Dallesasse’s testimony and Patent Owner’s position that the scope of claim 1 does not encompass linear compensation methods effected by analog pre-distortion.” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“mapping is based on an analog feedback loop, by . . . quoting from the reference and leaving out the very next sentence” has merit. Sur-Reply 8 (citing Pet. Reply 23). Petitioner does not sufficiently address the cited teachings and in particular, Taraschuk’s teachings of calculating a difference between a “sampled analog output signal (S) and corresponding M-bit word” to a calculate a mapping “required to obtain the desired output analog signal level.” Ex. 1006, 7:34–39. We are persuaded Petitioner does not sufficiently rebut Patent Owner’s contention that Roberts’ and Taraschuk’s teachings of linear compensation are implemented by analog pre-distortion. Petitioner cannot ignore these teachings of Taraschuk and consider only the portions that support its challenge. See Pet. Reply 17 (citing Pet. 43–45; Ex.1006, 7:56–60) (“Patent Owner’s emphasis on Taraschuk’s digital feedback loop is also misplaced because the Petition simply relied on Taraschuk’s linearizer 44 as a discrete, known device for performing non-linear compensation of a Mach-Zehnder modulator.” (emphasis added)). Petitioner cannot set forth the teachings of Taraschuk in such a piecemeal sufficiently explain why the converter of Taraschuk relies on analog pre-distortion, or explain why analog pre-distortion is encompassed by the invention recited in independent claim 1, Petitioner does not sufficiently carry its burden.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightNot shown unpatentableNot shown unpatentable
“Second, Petitioner concludes that “a POSITA would have found it obvious to map input bits to output bits within the look-up table such that the output bits correspond to voltage values to be transmitted to electrodes of an optical modulator,” but offers no support other than Robert’s teaching that the DSP’s output is a multi-bit parallel binary signal. See id. at 51 (citing Ex. 1005, 6:40–42). That is, the sole basis for Petitioner’s conclusion that it would have been obvious to perform the claimed method is that the output is the same. Id. This is impermissible hindsight. Third, Petitioner essentially argues that a person would have found it obvious to perform the mapping because Taraschuk teaches a look-up table and non-linear compensation. Id. at 51–52. Yet the claim recites how the mapping is performed, which is left unaddressed by Petitioner. Id. That is, Petitioner has not shown where Taraschuck teaches mapping a given number look-up table, so that the output bits compensate for the non-linear effects of the optical modulator. Id. at 52. Rather, Petitioner provides a piecemeal analysis that uses the ’872 patent’s specification as a blueprint to pull together a look-up table, non-linear compensation, and a modulator to arrive at the claimed invention. See id. Thus, all three rationales for limitation 1.9 are deficient. See PO Resp. 27.” slip op. at 30
- Skill levelSkill level petitioner adoptedOther
“We do not discern a substantial difference between the parties’ definitions for the level of ordinary skill in the art. Instead, we determine that the parties’ definitions are substantially similar. We adopt Petitioner’s definition of the level of skill in the art, which is consistent with the disclosure of the ’872 patent and asserted prior art of record. The findings and conclusions rendered in this Decision would not change had we adopted Patent Owner’s definition.” slip op. at 8
Patent outcomesUS 11,133,872 not shown unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,133,872
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.